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Find Clinical Drug Pipeline Developments & Deals by Nuvation Bio
The acquisition adds AnHeart’s lead asset, AB-106 (taletrectinib), a next-generation, potentially best-in-class ROS1 inhibitor with Breakthrough Therapy Designations currently completing two pivotal studies for patients with ROS1-positive non-small cell lung cancer.
The acquisition adds AnHeart’s lead asset, AB-106 (taletrectinib), a next-generation, potentially best-in-class ROS1 inhibitor with Breakthrough Therapy Designations currently completing two pivotal studies for patients with ROS1-positive non-small cell lung cancer.
NUV-1511, the first clinical DDC platform candidate, being evaluated for advanced solid tumors (HER2-negative metastatic breast cancer, metastatic castration-resistant prostate cancer) who previously received and progressed on or after treatment with Enhertu and/or Trodelvy.
NUV-1511 is the first clinical candidate from the company’s novel drug-drug conjugate (DDC) platform. It is being evaluated in preclinical studies for the treatment of advanced solid tumors.
Patients in the first regimen will be dosed with NUV-868 in combination with olaparib for the treatment of ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer and other solid tumors.
Decision to discontinue development of NUV-422 is result of an internal risk-benefit analysis factoring in feedback received from U.S. FDA in partial clinical hold letter for monotherapy Phase 1/2 study and clinical hold letters for its combination Phase 1b/2 studies.
Preclinical studies have shown that NUV-422 has favorable blood-brain barrier penetration. NUV-422 is also designed to limit CDK1 inhibition, a potential cause of toxicity in other second-generation inhibitors.
NUV-422, a selective small-molecule cyclin-dependent kinase (CDK) 2/4/6 inhibitor, has also received ODD for the treatment of patients with malignant gliomas and FTD for the treatment of high-grade gliomas from USFDA.
Company announced that the USFDA has granted FTD to NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, for the treatment of patients with high-grade gliomas, including glioblastoma multiforme.
NUV-422 is a selective small molecule resulting from Nuvation Bio's CDK inhibitor program. Patient enrollment and dosing is ongoing in the Phase 1/2 study of NUV-422 in adult patients with recurrent or refractory high-grade gliomas, including glioblastoma multiforme (GBM).
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